Safety and efficacy of a feed additive consisting of alpha‐amylase (produced with Bacillus licheniformis DSM 34315) (Ronozyme® HiStarch) for chickens for fattening, turkeys for fattening and minor growing poultry species (DSM Nutritional Products Ltd)
Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the alpha‐amylase (Ronozyme® HiStarch CT/L) produced with a genetically modified strain of Bacillus licheniformis (DSM 34315) as a zootechnical feed additive for ch...
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Wiley
2024-07-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2024.8846 |
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| author | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Mojca Durjava Birgit Dusemund Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Roberto Edoardo Villa Ruud Woutersen Paul Brantom Miguel Prieto Montserrat Anguita Jaume Galobart Matteo L. Innocenti Jordi Ortuño Elisa Pettenati Fabiola Pizzo Rosella Brozzi |
| author_facet | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Mojca Durjava Birgit Dusemund Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Roberto Edoardo Villa Ruud Woutersen Paul Brantom Miguel Prieto Montserrat Anguita Jaume Galobart Matteo L. Innocenti Jordi Ortuño Elisa Pettenati Fabiola Pizzo Rosella Brozzi |
| author_sort | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
| collection | DOAJ |
| description | Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the alpha‐amylase (Ronozyme® HiStarch CT/L) produced with a genetically modified strain of Bacillus licheniformis (DSM 34315) as a zootechnical feed additive for chickens for fattening, turkeys for fattening and minor growing poultry species. The additive is available in two forms, a coated thermotolerant granulate formulation and a liquid formulation. The production strain and its DNA were not detected in an intermediate concentrated product representative of the final formulations. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the final product did not trigger safety concerns with regard to the genetic modification. The Panel concluded that Ronozyme® HiStarch CT/L is safe for chickens for fattening, turkeys for fattening and minor growing poultry species at the recommended inclusion level of 80 KNU/kg complete feed. The use of Ronozyme® HiStarch CT/L in animal nutrition under the proposed conditions of use is safe for the consumers and the environment. The additive in any form was shown to be non‐irritant to the skin and the solid form was shown to be non‐irritant to the eyes. No conclusions could be drawn on the potential of the liquid form to be irritant to the eyes or on the potential of both forms of the additive to be dermal sensitisers due to lack of data. Owing to the proteinaceous nature of the active substance, the additive in either form was considered to be a respiratory sensitiser and any exposure by inhalation is considered a risk. In the absence of data, the Panel was not in the position to conclude on the efficacy of Ronozyme® HiStarch CT/L for chickens for fattening, turkeys for fattening and minor growing poultry species. |
| format | Article |
| id | doaj-art-2baa5ef6dcdc4e23a4e1efc48391f4a9 |
| institution | DOAJ |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-2baa5ef6dcdc4e23a4e1efc48391f4a92025-08-20T02:39:09ZengWileyEFSA Journal1831-47322024-07-01227n/an/a10.2903/j.efsa.2024.8846Safety and efficacy of a feed additive consisting of alpha‐amylase (produced with Bacillus licheniformis DSM 34315) (Ronozyme® HiStarch) for chickens for fattening, turkeys for fattening and minor growing poultry species (DSM Nutritional Products Ltd)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenMojca DurjavaBirgit DusemundMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosRoberto Edoardo VillaRuud WoutersenPaul BrantomMiguel PrietoMontserrat AnguitaJaume GalobartMatteo L. InnocentiJordi OrtuñoElisa PettenatiFabiola PizzoRosella BrozziAbstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the alpha‐amylase (Ronozyme® HiStarch CT/L) produced with a genetically modified strain of Bacillus licheniformis (DSM 34315) as a zootechnical feed additive for chickens for fattening, turkeys for fattening and minor growing poultry species. The additive is available in two forms, a coated thermotolerant granulate formulation and a liquid formulation. The production strain and its DNA were not detected in an intermediate concentrated product representative of the final formulations. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the final product did not trigger safety concerns with regard to the genetic modification. The Panel concluded that Ronozyme® HiStarch CT/L is safe for chickens for fattening, turkeys for fattening and minor growing poultry species at the recommended inclusion level of 80 KNU/kg complete feed. The use of Ronozyme® HiStarch CT/L in animal nutrition under the proposed conditions of use is safe for the consumers and the environment. The additive in any form was shown to be non‐irritant to the skin and the solid form was shown to be non‐irritant to the eyes. No conclusions could be drawn on the potential of the liquid form to be irritant to the eyes or on the potential of both forms of the additive to be dermal sensitisers due to lack of data. Owing to the proteinaceous nature of the active substance, the additive in either form was considered to be a respiratory sensitiser and any exposure by inhalation is considered a risk. In the absence of data, the Panel was not in the position to conclude on the efficacy of Ronozyme® HiStarch CT/L for chickens for fattening, turkeys for fattening and minor growing poultry species.https://doi.org/10.2903/j.efsa.2024.8846alpha‐amylasechickens for fatteningdigestibility enhancerefficacyRonozyme® HiStarch CT/Lsafety |
| spellingShingle | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Mojca Durjava Birgit Dusemund Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Roberto Edoardo Villa Ruud Woutersen Paul Brantom Miguel Prieto Montserrat Anguita Jaume Galobart Matteo L. Innocenti Jordi Ortuño Elisa Pettenati Fabiola Pizzo Rosella Brozzi Safety and efficacy of a feed additive consisting of alpha‐amylase (produced with Bacillus licheniformis DSM 34315) (Ronozyme® HiStarch) for chickens for fattening, turkeys for fattening and minor growing poultry species (DSM Nutritional Products Ltd) EFSA Journal alpha‐amylase chickens for fattening digestibility enhancer efficacy Ronozyme® HiStarch CT/L safety |
| title | Safety and efficacy of a feed additive consisting of alpha‐amylase (produced with Bacillus licheniformis DSM 34315) (Ronozyme® HiStarch) for chickens for fattening, turkeys for fattening and minor growing poultry species (DSM Nutritional Products Ltd) |
| title_full | Safety and efficacy of a feed additive consisting of alpha‐amylase (produced with Bacillus licheniformis DSM 34315) (Ronozyme® HiStarch) for chickens for fattening, turkeys for fattening and minor growing poultry species (DSM Nutritional Products Ltd) |
| title_fullStr | Safety and efficacy of a feed additive consisting of alpha‐amylase (produced with Bacillus licheniformis DSM 34315) (Ronozyme® HiStarch) for chickens for fattening, turkeys for fattening and minor growing poultry species (DSM Nutritional Products Ltd) |
| title_full_unstemmed | Safety and efficacy of a feed additive consisting of alpha‐amylase (produced with Bacillus licheniformis DSM 34315) (Ronozyme® HiStarch) for chickens for fattening, turkeys for fattening and minor growing poultry species (DSM Nutritional Products Ltd) |
| title_short | Safety and efficacy of a feed additive consisting of alpha‐amylase (produced with Bacillus licheniformis DSM 34315) (Ronozyme® HiStarch) for chickens for fattening, turkeys for fattening and minor growing poultry species (DSM Nutritional Products Ltd) |
| title_sort | safety and efficacy of a feed additive consisting of alpha amylase produced with bacillus licheniformis dsm 34315 ronozyme r histarch for chickens for fattening turkeys for fattening and minor growing poultry species dsm nutritional products ltd |
| topic | alpha‐amylase chickens for fattening digestibility enhancer efficacy Ronozyme® HiStarch CT/L safety |
| url | https://doi.org/10.2903/j.efsa.2024.8846 |
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